Successful Health Authority interactions are key factors in achieving drug product approvals that can have a positive impact on the approval timelines and overall costs. Since final decisions on drug product approvals with Health Canada, it is important to ensure that interactions with the authority (whether face-to-face, in writing or via teleconference) are conducted efficiently and effectively throughout the Regulatory process.
Health Authority interactions can be requested to Health Canada to understand the Bioequivalence study design and other expectations from Health Canada with respect to content, format and level of information required to be included in the Application Pre-submission meetings. Health Canada provides generic applicants with an opportunity to discuss and clarify expectations on the development plans and meetings that can help applicants identify potential risks and issues related to their ANDS applications so that the appropriate risk-mitigation strategies can be implemented to minimize the time to achieve approval.
Freyr, with expertise in handling the end-to-end registration activities for Health Canada, assists applicants in all types of formulations, different Regulatory submissions, procedural guidance and in understanding the concerns along with the compilation of appropriate responses with scientific justification to avoid further queries.
Pre-submission communications with the HA to confirm the formulation composition of the drug product
Preparation of meeting packages, documents, meeting plan, meeting minutes and communication results in alignment with Health Canada guidelines
Requesting scientific advice from HC before ANDS application submission
Implementation of relevant meeting strategy that covers overall objectives and fulfils the meeting’s goal
Follow-up activities and post-meeting requirements like submission of meeting minutes and development of program strategy based on Health Authority interactions
Evaluate query and formulation of appropriate response to the queries
Compilation of scientific justification in case of rejection of pre-submission meeting request
Correspondence with HC on day-to-day activities for clarifications on submission strategy